A Study To Evaluate Escalating Doses of A Vaccine-Based Immunotherapy Regimen For NSCLC and TNBC



Status:Recruiting
Conditions:Breast Cancer, Lung Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/15/2019
Start Date:November 27, 2018
End Date:November 11, 2021
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 1 STUDY TO EVALUATE THE SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF ESCALATING DOSES AND TREATMENT INTENSIFICATION OF A VACCINE-BASED IMMUNOTHERAPY REGIMEN-2 (VBIR-2) (PF-06936308) FOR ADVANCED NON-SMALL CELL LUNG CANCER AND METASTATIC TRIPLE-NEGATIVE BREAST CANCER

The study will evaluate the safety, pharmacokinetics and pharmacodynamics of increasing doses
of a vaccine-based immunotherapy regimen for patients with advanced non-small cell lung
cancer and metastatic triple-negative breast cancer.

By enrolling patients with advanced NSCLC and metastatic TNBC according to the enrollment
criteria, this study will evaluate the first-in-patient safety, PK, PD and early signs of
efficacy of the vaccine-based immunotherapy regimen.

Inclusion Criteria: -Histological or cytological diagnosis of non-small cell lung cancer or
triple-negative breast cancer

-Adequate bone marrow, kidney, and liver function

Exclusion Criteria:

- ECOG performance status greater than or equal to 2

- concurrent immunotherapy

- History of or active autoimmune disorders (including but not limited to: myasthenia
gravis, thyroiditis, pneumonitis, rheumatoid arthritis, multiple sclerosis, systemic
lupus, erythematosus, scleroderma) and other conditions that disorganize or alter the
immune system.

- History of inflammatory bowel disease.

- Current use of any implanted electronic stimulation device, such as cardiac demand
pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep
brain stimulators.

- Presence of any surgical or traumatic metal implants at the site of administration
We found this trial at
16
sites
3322 West End Avenue
Nashville, Tennessee 37203
(615)329-SCRI (7274)
Sarah Cannon Research Institute Sarah Cannon Research Institute (SCRI) is a global strategic research organization...
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12902 USF Magnolia Dr
Tampa, Florida 33612
(888) 663-3488
H. Lee Moffitt Cancer Center & Research Institute Moffitt Cancer Center in Tampa, Florida, has...
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Creve Coeur, Missouri 63141
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Creve Coeur, MO
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Fairway, KS
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Louisville, Kentucky 40202
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Louisville, KY
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Louisville, KY
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Louisville, Kentucky 40202
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Louisville, KY
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250 25th Ave N, Ste 100
Nashville, Tennessee 37023
615-320-5090
Tennessee Oncology, PLLC Since 1976 Tennessee Oncology has been providing quality cancer care. In 2013,...
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Saint Louis, Missouri 63110
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Saint Louis, MO
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660 S Euclid Ave
Saint Louis, Missouri 63110
(314) 362-5000
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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Saint Louis, MO
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Saint Louis, Missouri 63129
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Saint Peters, Missouri 63376
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Saint Peters, MO
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Salt Lake City, UT
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Salt Lake City, UT
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Seattle, WA
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Westwood, KS
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